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CTRI Number  CTRI/2023/05/053157 [Registered on: 26/05/2023] Trial Registered Prospectively
Last Modified On: 02/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study Of Polyherbal Oils In Osteoarthritis 
Scientific Title of Study   “A COMPARATIVE STUDY ON THE EFFICACY OF ABHYAṄGA AND PÄ€NA OF NIRGUṆḌI-TAILA IN THE MANAGEMENT OF SANDHIGATA-VÄ€TA IN PURVIEW OF “bāhyābhyantarataḥsnÄ“hairasthimajjagataṁjayÄ“t”,  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pooja Parashar 
Designation  M.D.second year scholar  
Affiliation  National Institute of Ayurveda 
Address  Department of Samhita and Maulika Siddhata Room no. 102 ,National Institute of Ayurveda ,Deemed to be University (De-novo),Jorawar Singh Gate,Amer road,Jaipur,(Raj.)pin-302002

Jaipur
RAJASTHAN
302002
India 
Phone  8602760176  
Fax    
Email  poojaparashar101@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nisha Gupta 
Designation  professor  
Affiliation  National Institute of Ayurveda 
Address  Department of Samhita and Maulika Siddhata Room no.102 ,National Institute of Ayurveda ,Deemed to be university (De-novo),Jorawar Singh Gate,Amer road,Jaipur,(Raj.)pin-302002

Jaipur
RAJASTHAN
302002
India 
Phone  9828087640  
Fax    
Email  guptadr.nisha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Parashar 
Designation  M.D.second year scholar  
Affiliation  National Institute of Ayurveda 
Address  Department Of Samhita And Maulika Siddhata Room no.102 ,National Institute Of Ayurveda ,Deemed to be university (De-novo),Jorawar Singh Gate,Amer road,Jaipur,(Raj.)pin-302002

Jaipur
RAJASTHAN
302002
India 
Phone  8602760176  
Fax    
Email  poojaparashar101@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jaipur 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda, Jorawar Singh Gate Amer road Jaipur 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pooja Parashar  National Institute of Ayurveda Hospital Jaipur  Department of Ayurveda Samhita & Maulika Samhita National Institute of Ayurveda jorawar singh gate amer road jaipur Rajasthan
Jaipur
RAJASTHAN 		 8602760176

poojaparashar101@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee National institute of ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition:M150||Primary generalized (osteo)arthritis. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Caraka Samhitā’cikitsāsthāna chapter 28/135vātavyādhiprakaraṇa, Procedure details: Abhyaṅga one time till 900mātrākāla(285sec.or 5min.every body part) approx.40 min.will be needed to complete full body massage. It will be performed for 30 days.)
(1) Medicine Name: nirgundi taila, Reference: Caraka Samhitā’cikitsāsthāna chapter 28/135vātavyādhiprakaraṇa, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 30 Days
2Comparator ArmDrugClassical(1) Medicine Name: nirgundi taila, Reference: Caraka Samhitā’cikitsāsthāna chapter 28/135vātavyādhiprakaraṇa, Route: Oral, Dosage Form: Taila, Dose: 24(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -as per agni
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with clinical feature of sandhigata vāta as described in classic texts.
Patients with chronicity of less than 10 years.

 
 
ExclusionCriteria 
Details  Patients who are below age of 30 year or over age of 60 year.
Patients having severe joint deformities.(permanent joint deformities)
Patients suffering from whole body paralysis (Quadriplegia).
Patients having any type of arthropathy other than osteoarthritis such as neoplasm of spine, ankylosis spondylitis, traumatic arthritis , pyogenic osteomyelitis, gout etc.
Patients having associated cardiac disease, tuberculosis, malignant .
Patients contraindicated for snehapāna and abhyaṅga in Āyurveda classical text.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 

Changes in the Visual Analogue Scale (VAS),and Womac scale.

 		 7th day, 14th day, 21th day, 30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
Change in ESR,CBC,Lipid Profile  Before treatment and after treatment  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
NEED OF STUDY:
Therapeutically in present era multiple regimens have been described in different classics of Āyurveda, but potent and durable results are not found as a result of non-eradication of the root cause. Hence its special emphasis or searching for more effective and suitable drug for osteoarthritis should be done.
Āyurveda provides the best alternative option for the management of osteoarthritis. According to classical text Aṣṭāṅgahṛdaya, sandhigata vāta is managed by repeated use of snehana, swedana, basti and mṛuduvirecana therapies.
Ä€cārya SuÅ›ruta has mentioned snehana, upanāha, agnikarma, bandhana and unmardana for the treatment for sandhigata vāta.Ä€cārya Caraka has mentioned snehana, swedana, má¹›duvirecana, bastikarma for the treatment of vātavyādhi.One should overcome the vāta located in asthi and majjā by applying unction externally as well as internally. 
Ä€gni will have to be evaluated especially while giving the sneha internally. But for proper assessment of results using the principles of statistics in the feild of research, stable dose will be more suitable. Thus Nirguṇḍi taila will be given in same quantity in all patients but as per the status of their āgni, time of consumption of food will be managed accordingly. 
Here ‘Nirguṇḍi taila’ abhyaṅga and ‘Nirguṇḍi taila’ pāna are selected for this study.
‘Nirguṇḍi taila’ is mentioned in ‘Caraka Samhitā’cikitsāsthāna chapter 28vātavyādhiprakaraṇa for both internal and external use. 
Above mentioned drugs are easily available, effective and easy to administer in the patients. Also internal as well as external use of sneha will be effective in sandhigata vāta in comparison to mere kwath preparations which are basically dry in their nature.
These are the basic reasons for the selection of these abovementioned  drugs for present clinical trial. 
Research question: Is there  any difference between the efficacy of Nirguṇḍi taila abhyaá¹…ga and Nirguṇḍi taila pāna in the management of sandhigata vāta ?
 
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